IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents
2 other identifiers
observational
1,207
2 countries
39
Brief Summary
This study will examine the long-term effects of HIV infection, highly active antiretroviral therapy (HAART), and experimental treatments on children who participated in PACTG 219C or select IMPAACT studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 25, 2015
October 1, 2014
4.3 years
February 1, 2010
March 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To identify possible long-term adverse outcomes of HIV infection and complications of antiretroviral therapy (ART) or experimental interventions other than ARTs in HIV-infected infants, children, and adolescents at IMPAACT sites in the United States
Throughout the study
Study Arms (1)
HIV-infected infants, children, and adolescents
Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies.
Eligibility Criteria
The study population will include participants in PACTG 219C or select IMPAACT treatment studies.
You may qualify if:
- Past or current documentation of a confirmed diagnosis of HIV-1 infection defined as two separate peripheral blood specimens from different days, and each specimen must be positive. More information on this criterion can be found in the protocol.
- HIV-infected infants, children, or adolescents who participated in PACTG 219C during 5/1/06-5/31/07 and are not currently participating in ongoing long-term follow-up (LTFU) studies (e.g., Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol \[PHACS AMP\], LEGACY). Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
- HIV-infected infants, children, and adolescents at domestic sites who have participated in or are currently participating in IMPAACT treatment studies (including studies that have rolled over from the PACTG into IMPAACT) designated by the IMPAACT Network Executive Committee (NEC) for subsequent LTFU in this study, and are not currently participating in ongoing LTFU studies. Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
- Parent or legally-accepted representative/guardian is able and willing to provide signed informed consent for minors (unless child has emancipated minor status)
You may not qualify if:
- Current participation in other ongoing LTFU studies (e.g., PHACS AMP, LEGACY). Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, 35294, United States
Miller Children's Hospital Long Beach (5093)
Long Beach, California, 90806, United States
Usc La Nichd Crs (5048)
Los Angeles, California, 90033, United States
Childrens Hospital Los Angeles (5090)
Los Angeles, California, 90054, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, 90095, United States
UCSD Mother, Child & Adolescent HIV Program(4601)
San Diego, California, 92103, United States
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, 94117, United States
University of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, 80045, United States
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington D.C., District of Columbia, 20010, United States
Howard University Washington DC NICHD CRS (5044)
Washington D.C., District of Columbia, 20060, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, 33316, United States
Univ. of Florida Jacksonville NICHD CRS (5051)
Jacksonville, Florida, 32209, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
Miami, Florida, 33136, United States
University of South Florida Tampa (5018)
Tampa, Florida, 33620, United States
Chicago Children's CRS (4001)
Chicago, Illinois, 60614, United States
Tulane University (5095)
New Orleans, Louisiana, 70112, United States
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, 21287, United States
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, 02115, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, 01605, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, Michigan, 48201, United States
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, 07103, United States
Univ of Med & Dentistry of New Jersey/Univ Hosp
Newark, New Jersey, 07103, United States
New York University NY (5012)
New York, New York, 10016, United States
Metropolitan Hospital (5003)
New York, New York, 10029, United States
Columbia IMPAACT Center (4101)
New York, New York, 10032, United States
Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, New York, 14642, United States
SUNY Stony Brook (5040)
Stony Brook, New York, 11794-8111, United States
Bronx-Lebanon Hospital IMPAACT CRS (6901)
The Bronx, New York, 10457, United States
Jacobi Medical Center Bronx (5013)
The Bronx, New York, 10461, United States
Duke Pediatric Infectious Diseases
Durham, North Carolina, 27710-3499, United States
Duke University Medical Center (DUMC) Pediatric CRS (4701)
Durham, North Carolina, 27710, United States
The Children's Hospital of Philadelphia IMPAACT CRS (6701)
Philadelphia, Pennsylvania, 19104, United States
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, 38105-2794, United States
Texas Children's Hosp. CRS (3801)
Houston, Texas, 77030, United States
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, 98105, United States
Seattle Children's Hospital CRS (5017)
Seattle, Washington, 98105, United States
University of Washington NICHD CRS (5029)
Seattle, Washington, 98105, United States
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, 00927, Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, 00936-5067, Puerto Rico
Related Publications (2)
Patel K, Hernan MA, Williams PL, Seeger JD, McIntosh K, Van Dyke RB, Seage GR 3rd; Pediatric AIDS Clinical Trials Group 219/219C Study Team. Long-term effectiveness of highly active antiretroviral therapy on the survival of children and adolescents with HIV infection: a 10-year follow-up study. Clin Infect Dis. 2008 Feb 15;46(4):507-15. doi: 10.1086/526524.
PMID: 18199042BACKGROUNDBrady MT, Oleske JM, Williams PL, Elgie C, Mofenson LM, Dankner WM, Van Dyke RB; Pediatric AIDS Clinical Trials Group219/219C Team. Declines in mortality rates and changes in causes of death in HIV-1-infected children during the HAART era. J Acquir Immune Defic Syndr. 2010 Jan;53(1):86-94. doi: 10.1097/QAI.0b013e3181b9869f.
PMID: 20035164BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Myron J. Levin, MD
University of Colorado at Denver Health Sciences Center
- STUDY CHAIR
Paige L. Williams, PhD
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 2, 2010
Study Start
March 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2014
Last Updated
March 25, 2015
Record last verified: 2014-10